MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235350-23
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	03/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information the device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of dissection, as listed in the absorb gt1 instructions for use, is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.The investigation determined the reported difficulties and additional therapy appear to be related to circumstances of the procedure; however a conclusive cause for the reported patient effect cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a non-calcified, de novo lesion in the mildly tortuous circumflex (cx) coronary artery.A 3.5x23mm absorb gt1 bioresorbable vascular scaffold (bvs) system was advanced and deployed without difficulty at 10 atmospheres when a distal edge dissection was observed.The absorb gt1 delivery system was withdrawn without difficulty.An attempt was made to advance a 3.0x12mm absorb gt1 bvs system through the deployed 3.5x23mm absorb gt1 scaffold, however, it was unable to cross through this scaffold and was withdrawn without resistance.No damage was caused to either absorb scaffold.A 3.0x12 xience alpine stent crossed and was deployed, successfully treating the dissection.There were no adverse patient sequelae and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6481084
• Report Number: 2024168-2017-03016
• Device Sequence Number: 11084900
• Product Code: PNY
• UDI-Device Identifier: 08717648213137
• UDI-Public: (01)08717648213137(17)170911(10)6091261
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2017
• Device Catalogue Number: 1235350-23
• Device Lot Number: 6091261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 101